A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
1 other identifier
interventional
1,650
18 countries
349
Brief Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2023
Longer than P75 for phase_3
349 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 6, 2023
CompletedFirst Posted
Study publicly available on registry
January 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2032
April 17, 2026
April 1, 2026
8.9 years
December 6, 2023
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Cohort 1 Only: Resolution of NASH/MASH and a ≥ 1 stage improvement in fibrosis
Based on NAS (scored by 0-1 for steatosis, 0-3 for inflammation, and 0-2 for ballooning) and NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)
52 Weeks
Event-free survival
Based on time from randomization to the first clinical event including evidence of disease progression, liver decompensation events, liver transplantation or eligibility for liver transplantation, and all-cause mortality.
240 Weeks
Secondary Outcomes (16)
Cohort 1 Only: Resolution of NASH/MASH and no worsening of fibrosis
52 Weeks
Cohort 1 Only: ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis
52 Weeks
Change from baseline of non-invasive markers of liver fibrosis
52 Weeks, 240 Weeks
Change from baseline of non-invasive markers of liver fibrosis
52 Weeks, 240 Weeks
Change from baseline of non-invasive markers of liver fibrosis
52 Weeks, 240 Weeks
- +11 more secondary outcomes
Study Arms (3)
EFX 28 mg
EXPERIMENTALEFX 50 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
- Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
- Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:
- Steatosis (scored 0 to 3),
- Ballooning degeneration (scored 0 to 2), and
- Lobular inflammation (scored 0 to 3).
You may not qualify if:
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results.
- Presence of cirrhosis on liver biopsy (fibrosis stage 4).
- Type 1 or uncontrolled Type 2 diabetes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (349)
Akero Clinical Study Site
Birmingham, Alabama, 35209, United States
Akero Clinical Study Site
Dothan, Alabama, 36301, United States
Akero Clinical Study Site
Chandler, Arizona, 85224, United States
Akero Clinical Study Site
Flagstaff, Arizona, 86001, United States
Akero Clinical Study Site
Mesa, Arizona, 85213, United States
Akero Clinical Study Site
Peoria, Arizona, 85381, United States
Akero Clinical Study Site
Tucson, Arizona, 85712, United States
Akero Clinical Study Site
Tucson, Arizona, 85712, United States
Akero Clinical Study Site
Tucson, Arizona, 85713, United States
Akero Clinical Study Site
Tucson, Arizona, 85715, United States
Akero Clinical Study Site
Conway, Arkansas, 72032, United States
Akero Clinical Study Site
Jonesboro, Arkansas, 72401, United States
Akero Clinical Study Site
Little Rock, Arkansas, 72205, United States
Akero Clinical Study Site
North Little Rock, Arkansas, 72117, United States
Akero Clinical Study Site
Chula Vista, California, 91910, United States
Akero Clinical Study Site
Coronado, California, 92118, United States
Akero Clinical Study Site
Escondido, California, 92025, United States
Akero Clinical Study Site
Folsom, California, 95630, United States
Akero Clinical Study Site
Inglewood, California, 90301, United States
Akero Clinical Study Site
La Mesa, California, 91942, United States
Akero Clinical Study Site
Lancaster, California, 93534, United States
Akero Clinical Study Site
Lancaster, California, 93534, United States
Akero Clinical Study Site
Long Beach, California, 90815, United States
Akero Clinical Study Site
Los Angeles, California, 90036, United States
Akero Clinical Study Site
Los Angeles, California, 90048, United States
Akero Clinical Study Site
Los Angeles, California, 90057, United States
Akero Clinical Study Site
Newport Beach, California, 92663, United States
Akero Clinical Study Site
Orange, California, 92868, United States
Akero Clinical Study Site
Palm Springs, California, 92262, United States
Akero Clinical Study Site
Pasadena, California, 91105, United States
Akero Clinical Study Site
Redwood City, California, 94063, United States
Akero Clinical Study Site
Sacramento, California, 95817, United States
Akero Clinical Study Site
San Diego, California, 92120, United States
Akero Clinical Study Site
San Diego, California, 92123, United States
Akero Clinical Study Site
San Diego, California, 92161, United States
Akero Clinical Study Site
San Francisco, California, 94115, United States
Akero Clinical Study Site
San Francisco, California, 94117, United States
Akero Clinical Study Site
Santa Maria, California, 93458, United States
Akero Clinical Study Site
Aurora, Colorado, 80045, United States
Akero Clinical Study Site
Colorado Springs, Colorado, 80907, United States
Akero Clinical Study Site
Englewood, Colorado, 80113, United States
Akero Clinical Study Site
New Haven, Connecticut, 06520, United States
Akero Clinical Study Site
Washington D.C., District of Columbia, 20007, United States
Akero Clinical Study Site
Washington D.C., District of Columbia, 20422, United States
Akero Clinical Study Site
Bradenton, Florida, 34208, United States
Akero Clinical Study Site
Brandon, Florida, 33511, United States
Akero Clinical Study Site
Doral, Florida, 33126, United States
Akero Clinical Study Site
Fort Myers, Florida, 33912, United States
Akero Clinical Study Site
Gainesville, Florida, 32610, United States
Akero Clinical Study Site
Hialeah Gardens, Florida, 33016, United States
Akero Clinical Study Site
Inverness, Florida, 34452, United States
Akero Clinical Study Site
Jacksonville, Florida, 32256, United States
Akero Clinical Study Site
Lady Lake, Florida, 32159, United States
Akero Clinical Study Site
Lakewood Rch, Florida, 34211, United States
Akero Clinical Study Site
Largo, Florida, 33777, United States
Akero Clinical Study Site
Lehigh Acres, Florida, 33936, United States
Akero Clinical Study Site
Maitland, Florida, 32751, United States
Akero Clinical Study Site
Margate, Florida, 33063, United States
Akero Clinical Study Site
Miami, Florida, 33136, United States
Akero Clinical Study Site
Miami, Florida, 33175, United States
Akero Clinical Study Site
Miami Gardens, Florida, 33014, United States
Akero Clinical Study Site
Miami Lakes, Florida, 33016, United States
Akero Clinical Study Site
Naples, Florida, 34102, United States
Akero Clinical Study Site
New Port Richey, Florida, 34653, United States
Akero Clinical Study Site
Ocala, Florida, 34471, United States
Akero Clinical Study Site
Orlando, Florida, 32807, United States
Akero Clinical Study Site
Pembroke Pines, Florida, 33027, United States
Akero Clinical Study Site
Port Orange, Florida, 32127, United States
Akero Clinical Study Site
Riverview, Florida, 33578, United States
Akero Clinical Study Site
Sarasota, Florida, 34240, United States
Akero Clinical Study Site
Temple Terrace, Florida, 33617, United States
Akero Clinical Study Site
Venice, Florida, 34285, United States
Akero Clinical Study Site
Viera, Florida, 32940, United States
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West Palm Beach, Florida, 33401, United States
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Weston, Florida, 33331, United States
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Winter Park, Florida, 32789, United States
Akero Clinical Study Site
Winter Park, Florida, 32792, United States
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Zephyrhills, Florida, 33542, United States
Akero Clinical Study Site
Atlanta, Georgia, 30309, United States
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Columbus, Georgia, 31904, United States
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Gainesville, Georgia, 30501, United States
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Marietta, Georgia, 30060, United States
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Chicago, Illinois, 60637, United States
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Hammond, Indiana, 46324, United States
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Indianapolis, Indiana, 46202, United States
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South Bend, Indiana, 46635, United States
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West Des Moines, Iowa, 50265, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67205, United States
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Louisville, Kentucky, 40202, United States
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Bastrop, Louisiana, 71220, United States
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Covington, Louisiana, 70433, United States
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Houma, Louisiana, 70363, United States
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Marrero, Louisiana, 70072, United States
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Marrero, Louisiana, 70072, United States
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Metairie, Louisiana, 70006, United States
Akero Clinical Study Site
New Orleans, Louisiana, 70112, United States
Akero Clinical Study Site
New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71105, United States
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West Monroe, Louisiana, 71291, United States
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Baltimore, Maryland, 21202, United States
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Glen Burnie, Maryland, 21061, United States
Akero Clinical Study Site
Greenbelt, Maryland, 20770, United States
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South Dartmouth, Massachusetts, 02747, United States
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Novi, Michigan, 48377, United States
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Southfield, Michigan, 48075, United States
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Wyoming, Michigan, 49519, United States
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Ypsilanti, Michigan, 48197, United States
Akero Clinical Study Site
Flowood, Mississippi, 39232, United States
Akero Clinical Study Site
Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64131, United States
Akero Clinical Study Site
St Louis, Missouri, 63123, United States
Akero Clinical Study Site
Las Vegas, Nevada, 89106, United States
Akero Clinical Study Site
Las Vegas, Nevada, 89109, United States
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Reno, Nevada, 89511, United States
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Florham Park, New Jersey, 07932, United States
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Ridgewood, New Jersey, 07450, United States
Akero Clinical Study Site
Somers Point, New Jersey, 08244, United States
Akero Clinical Study Site
Sparta, New Jersey, 07871, United States
Akero Clinical Study Site
Santa Fe, New Mexico, 87505, United States
Akero Clinical Study Site
Buffalo, New York, 14203, United States
Akero Clinical Study Site
New York, New York, 10016, United States
Akero Clinical Study Site
New York, New York, 10021, United States
Akero Clinical Study Site
New York, New York, 10029, United States
Akero Clinical Study Site
New York, New York, 10033, United States
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Rochester, New York, 55905, United States
Akero Clinical Study Site
Chapel Hill, North Carolina, 27514, United States
Akero Clinical Study Site
Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27710, United States
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Fayetteville, North Carolina, 28303, United States
Akero Clinical Study Site
Morehead City, North Carolina, 28557, United States
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New Bern, North Carolina, 28562, United States
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Raleigh, North Carolina, 27612, United States
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Statesville, North Carolina, 28625, United States
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Columbus, Ohio, 43213, United States
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Dayton, Ohio, 45414, United States
Akero Clinical Study Site
Springboro, Ohio, 45066, United States
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Westlake, Ohio, 44145, United States
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Medford, Oregon, 97504, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Charleston, South Carolina, 29425, United States
Akero Clinical Study Site
Columbia, South Carolina, 29204, United States
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Summerville, South Carolina, 29485, United States
Akero Clinical Study Site
Chattanooga, Tennessee, 37421, United States
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Clarksville, Tennessee, 37040, United States
Akero Clinical Study Site
Hermitage, Tennessee, 37076, United States
Akero Clinical Study Site
Nashville, Tennessee, 37211, United States
Akero Clinical Study Site
Amarillo, Texas, 79106, United States
Akero Clinical Study Site
Austin, Texas, 78745, United States
Akero Clinical Study Site
Austin, Texas, 78757, United States
Akero Clinical Study Site
Austin, Texas, 78757, United States
Akero Clinical Study Site
Bellaire, Texas, 77401, United States
Akero Clinical Study Site
Brownsville, Texas, 78520, United States
Akero Clinical Study Site
Corpus Christi, Texas, 78404, United States
Akero Clinical Study Site
Dallas, Texas, 75203, United States
Akero Clinical Study Site
Dallas, Texas, 75216, United States
Akero Clinical Study Site
Dallas, Texas, 75230, United States
Akero Clinical Study Site
Dallas, Texas, 75234, United States
Akero Clinical Study Site
Dallas, Texas, 75390, United States
Akero Clinical Study Site
Denison, Texas, 75020, United States
Akero Clinical Study Site
Edinburg, Texas, 78539, United States
Akero Clinical Study Site
Edinburg, Texas, 78539, United States
Akero Clinical Study Site
Forney, Texas, 75126, United States
Akero Clinical Study Site
Fort Worth, Texas, 76104, United States
Akero Clinical Study Site
Houston, Texas, 77030, United States
Akero Clinical Study Site
Houston, Texas, 77030, United States
Akero Clinical Study Site
Houston, Texas, 77074, United States
Akero Clinical Study Site
Houston, Texas, 77079, United States
Akero Clinical Study Site
Houston, Texas, 77079, United States
Akero Clinical Study Site
Houston, Texas, 77084, United States
Akero Clinical Study Site
Lewisville, Texas, 75057, United States
Akero Clinical Study Site
McAllen, Texas, 78504, United States
Akero Clinical Study Site
Pasadena, Texas, 77505, United States
Akero Clinical Study Site
San Antonio, Texas, 78209, United States
Akero Clinical Study Site
San Antonio, Texas, 78215, United States
Akero Clinical Study Site
San Antonio, Texas, 78222, United States
Akero Clinical Study Site
San Antonio, Texas, 78229, United States
Akero Clinical Study Site
San Antonio, Texas, 78229, United States
Akero Clinical Study Site
San Antonio, Texas, 78240, United States
Akero Clinical Study Site
San Antonio, Texas, 78258, United States
Akero Clinical Study Site
San Marcos, Texas, 78666-7502, United States
Akero Clinical Study Site
San Marcos, Texas, 78666, United States
Akero Clinical Study Site
Waco, Texas, 76710, United States
Akero Clinical Study Site
Waco, Texas, 76712, United States
Akero Clinical Study Site
Webster, Texas, 77598, United States
Akero Clinical Study Site
Wichita Falls, Texas, 76301, United States
Akero Clinical Study Site
Ogden, Utah, 84405, United States
Akero Clinical Study Site
Salt Lake City, Utah, 84117, United States
Akero Clinical Study Site
Sandy City, Utah, 84092, United States
Akero Clinical Study Site
South Ogden, Utah, 84405, United States
Akero Clinical Study Site
Falls Church, Virginia, 22042-3300, United States
Akero Clinical Study Site
Newport News, Virginia, 23602, United States
Akero Clinical Study Site
Norfolk, Virginia, 23502, United States
Akero Clinical Study Site
Richmond, Virginia, 23226, United States
Akero Clinical Study Site
Richmond, Virginia, 23235, United States
Akero Clinical Study Site
Richmond, Virginia, 23249, United States
Akero Clinical Study Site
Richmond, Virginia, 23298, United States
Akero Clinical Study Site
Roanoke, Virginia, 24014, United States
Akero Clinical Study Site
Suffolk, Virginia, 23435, United States
Akero Clinical Study Site
Seattle, Washington, 98105, United States
Akero Clinical Study Site
Spokane, Washington, 99218, United States
Akero Clinical Study Site
Madison, Wisconsin, 53705, United States
Akero Clinical Study Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
Akero Clinical Study Site
La Plata, Buenos Aires, B1902AWL, Argentina
Akero Clinical Study Site
Ramos Mejía, Buenos Aires, B1704ETD, Argentina
Akero Clinical Study Site
Buenos Aires, Distrito Federal, C1125ABE, Argentina
Akero Clinical Study Site
Buenos Aires, C1118AAT, Argentina
Akero Clinical Study Site
Buenos Aires, C1180AAX, Argentina
Akero Clinical Study Site
Buenos Aires, C1280AEB, Argentina
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Broadmeadow, New South Wales, 2292, Australia
Akero Clinical Study Site
Kogarah, New South Wales, 2217, Australia
Akero Clinical Study Site
Liverpool, New South Wales, 1871, Australia
Akero Clinical Study Site
Penrith, New South Wales, 2750, Australia
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Westmead, New South Wales, 2145, Australia
Akero Clinical Study Site
Adelaide, South Australia, 5000, Australia
Akero Clinical Study Site
Caulfield South, Victoria, 3162, Australia
Akero Clinical Study Site
Epping, Victoria, 3076, Australia
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Frankston, Victoria, 3128, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Murdoch, Western Australia, 6150, Australia
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Nedlands, Western Australia, 6009, Australia
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Perth, Western Australia, 6000, Australia
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Edmonton, Alberta, T6G 2X8, Canada
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Hamilton, Ontario, L8S 4K1, Canada
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Toronto, Ontario, M6H 3M1, Canada
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Vaughan, Ontario, L4L 4Y7, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Terrebonne, Quebec, J7B6B7, Canada
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Nice, Alpes-Maritimes, 06202, France
Akero Clinical Study Site
Lyon, Auvergne-Rhône-Alpes, 69008, France
Akero Clinical Study Site
Strasbourg, Bas-Rhin, 67091, France
Akero Clinical Study Site
Limoges, Haute-Vienne, 87042, France
Akero Clinical Study Site
Clichy, Hauts-de-Seine, 92110, France
Akero Clinical Study Site
Vandœuvre-lès-Nancy, Lorraine, 54511, France
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Angers, Maine-et-Loire, 49933, France
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Toulouse, Occitanie, 31059, France
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Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France
Akero Clinical Study Site
Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, 34295, France
Akero Clinical Study Site
Créteil, Val-De-Marne, 94010, France
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Versailles, Yvelines, Île-de-France, 78000, France
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Paris, Île-de-France Region, 75013, France
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Würzburg, Bavaria, 97080, Germany
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Frankfurt am Main, Hesse, 60590, Germany
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Mainz, Rhineland-Palatinate, 55131, Germany
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Homburg, Saarland, 66421, Germany
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Leipzig, Saxony, 04103, Germany
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Leipzig, Saxony, 04103, Germany
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Leipzig, Saxony, 04103, Germany
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Lübeck, Schleswig-Holstein, 23538, Germany
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Berlin, 10787, Germany
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Berlin, 13353, Germany
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Surat, Gujarat, 395002, India
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Vadodara, Gujarat, 390007, India
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Thiruvananthapuram, Kerala, 695011, India
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Dahegaon, Maharashtra, 441108, India
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Nagpur, Maharashtra, 440010, India
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Pune, Maharashtra, 412201, India
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New Delhi, National Capital Territory of Delhi, 110029, India
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New Delhi, National Capital Territory of Delhi, 110060, India
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Jaipur, Rajasthan, 302001, India
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Jaipur, Rajasthan, 302001, India
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Coimbatore, Tamil Nadu, 641005, India
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Hyderabad, Telangana, 500 004, India
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Varanasi, Uttar Pradesh, 221005, India
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Kolkata, West Bengal, 700020, India
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Kolkata, West Bengal, 700020, India
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Kolkata, West Bengal, 700073, India
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Petah Tikva, Central District, 4941492, Israel
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Ramat Gan, Central District, 5265601, Israel
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Haifa, Haifa District, 3109601, Israel
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Haifa, Haifa District, 3436212, Israel
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Afula, Northern District, 1834111, Israel
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Nahariya, Northern District, 22100, Israel
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Nazareth, Northern District, 1610001, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Tel Aviv, 6423906, Israel
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San Giovanni Rotondo, Foggia, 71013, Italy
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Rozzano, Milan, 20089, Italy
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Torino, Turin, 10126, Italy
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Bologna, 40138, Italy
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Foggia, 71122, Italy
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Messina, 98124, Italy
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Milan, 20122, Italy
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Milan, 20122, Italy
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Modena, 41126, Italy
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Naples, 80131, Italy
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Novara, 28100, Italy
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Cuauhtémoc, Mexico City, 06700, Mexico
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Poznan, Greater Poland Voivodeship, 60-702, Poland
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Krakow, Lesser Poland Voivodeship, 31-501, Poland
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Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
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Wroclaw, Lower Silesian Voivodeship, 53-673, Poland
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Warsaw, Masovian Voivodeship, 00-215, Poland
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Warsaw, Masovian Voivodeship, 02-672, Poland
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Gdansk, Pomeranian Voivodeship, 80-382, Poland
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Gdynia, Pomeranian Voivodeship, 81-537, Poland
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Częstochowa, Silesian Voivodeship, 42-202, Poland
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Katowice, Silesian Voivodeship, 40-040, Poland
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Katowice, Silesian Voivodeship, 40-081, Poland
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Lodz, Łódź Voivodeship, 90-127, Poland
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Manati, 00674, Puerto Rico
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Mayagüez, 00680, Puerto Rico
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San Juan, 00927, Puerto Rico
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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], 41944, South Korea
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Goyang-si, Gyeonggi-do, 1232, South Korea
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Incheon, Gyeonggi-do, 22332, South Korea
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Seongnam-si, Gyeonggi-do, 13620, South Korea
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Seongnam-si, Gyeonggido [Kyonggi-do], 13520, South Korea
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Daegu, Gyeongsangbugdo [Kyongsangbuk-do], 42601, South Korea
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080, South Korea
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 04763, South Korea
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Sabadell, Barcelona, 08208, Spain
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Santander, Cantabria, 39008, Spain
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Majadahonda, Madrid, 28222, Spain
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Valencia, València, 46015, Spain
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Valencia, València, 46026, Spain
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Barcelona, 08035, Spain
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Madrid, 28007, Spain
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Madrid, 28027, Spain
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Seville, 41013, Spain
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Olten, Canton of Solothurn, 4600, Switzerland
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Bern, 3010, Switzerland
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Sankt Gallen, 9007, Switzerland
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Changhua, Changhua, 500, Taiwan
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Taichung, Taichung, 40447, Taiwan
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Tainan, Tainan, 73657, Taiwan
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Taipei City, Taipei, 10048, Taiwan
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Kaohsiung City, 833, Taiwan
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Tainan, 704, Taiwan
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Taoyuan District, 333, Taiwan
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Yenimahalle, Ankara, 06500, Turkey (Türkiye)
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Bornova, İzmir, 35100, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Rize, 53020, Turkey (Türkiye)
Akero Clinical Study Site
Birmingham, England, B15 2WB, United Kingdom
Akero Clinical Study Site
Cambridge, England, CB2 0QQ, United Kingdom
Akero Clinical Study Site
Liverpool, England, L9 7AL, United Kingdom
Akero Clinical Study Site
London, England, E1 1BB, United Kingdom
Akero Clinical Study Site
London, England, NW3 2QG, United Kingdom
Akero Clinical Study Site
London, England, SE5 9RS, United Kingdom
Akero Clinical Study Site
London, England, SW10 9NH, United Kingdom
Akero Clinical Study Site
London, England, W2 1NY, United Kingdom
Akero Clinical Study Site
Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2023
First Posted
January 22, 2024
Study Start
December 1, 2023
Primary Completion (Estimated)
November 1, 2032
Study Completion (Estimated)
November 1, 2032
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share